Department of Radiation Oncology, University of Maryland, Baltimore, MD, USA,
Ann Surg Oncol. 2011 May;18(5):1319-26. doi: 10.1245/s10434-011-1630-6. Epub 2011 Mar 10.
The impact of the addition of gemcitabine to 5-fluorouracil (5-FU) chemoradiation (CRT) on 5-year overall survival (OS) in resected pancreatic adenocarcinoma are presented with updated results of a phase III trial.
After resection of pancreatic adenocarcinoma, patients were randomized to pre- and post-CRT 5-FU versus pre- and post-CRT gemcitabine. 5-FU was provided continuously at 250 mg/m(2)/day, and gemcitabine was provided at 1000 mg/m(2) weekly. Both were provided over 3 weeks before and 12 weeks after CRT. CRT was provided at 50.4 Gy with continuously provided 5-FU. The primary end point was survival for all patients and for patients with tumor of the pancreatic head.
Four hundred fifty-one patients were eligible. Univariate analysis showed no difference in OS. Pancreatic head tumor patients (n = 388) had a median survival and 5-year OS of 20.5 months and 22% with gemcitabine versus 17.1 months and 18% with 5-FU. On multivariate analysis, patients on the gemcitabine arm with pancreatic head tumors experienced a trend toward improved OS (P = 0.08). First site of relapse local recurrence in 28% of patients versus distant relapse in 73%.
The sequencing of 5-FU CRT with gemcitabine as done in this trial is not associated with a statistically significant improvement in OS. Despite local recurrence being approximately half of that reported in previous adjuvant trials, distant disease relapse still occurs in ≥ 70% of patients. These findings serve as the basis for the recently activated EORTC/U.S. Intergroup RTOG 0848 phase III adjuvant trial evaluating the impact of CRT after completion of a full course of gemcitabine.
吉西他滨联合氟尿嘧啶（5-FU）放化疗（CRT）对切除的胰腺腺癌 5 年总生存率（OS）的影响，本文报道了一项 III 期试验的更新结果。
在切除胰腺腺癌后，患者被随机分配至 CRT 前和后给予 5-FU 与 CRT 前和后给予吉西他滨。5-FU 持续 250mg/m²/天，吉西他滨每周 1000mg/m²。两者均在 CRT 前 3 周和后 12 周内提供。CRT 采用 50.4Gy 连续给予 5-FU。主要终点是所有患者和胰腺头部肿瘤患者的生存情况。
451 名患者符合条件。单因素分析显示 OS 无差异。胰腺头部肿瘤患者（n=388）的中位生存期和 5 年 OS 分别为 20.5 个月和 22%，接受吉西他滨治疗；17.1 个月和 18%接受 5-FU 治疗。多因素分析显示，胰腺头部肿瘤患者接受吉西他滨治疗组的 OS 有改善趋势（P=0.08）。首次复发部位为局部复发 28%，远处转移复发 73%。
本试验中 5-FU CRT 序贯吉西他滨治疗与 OS 的统计学显著改善无关。尽管局部复发率约为以前辅助试验报告的一半，但仍有≥70%的患者发生远处疾病复发。这些发现为最近启动的 EORTC/U.S. Intergroup RTOG 0848 期 III 辅助试验提供了依据，该试验评估了完成吉西他滨全程治疗后 CRT 的影响。
